The US patent US10815240B2 covers abrocitinib, a Janus kinase 1 (JAK1) inhibitor used to treat atopic dermatitis [1]. This patent is a key asset for Pfizer, the developer of abrocitinib, which is marketed as Cibinqo [2].
When does the abrocitinib patent expire?
The expiry date for US patent US10815240B2 is not explicitly stated in the provided information, but patent terms are typically 20 years from the filing date, subject to adjustments and potential extensions [3]. Information on specific patent expiry dates for abrocitinib can be found on DrugPatentWatch.com [4].
What is abrocitinib used for?
Abrocitinib is a targeted therapy approved for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy [2][5]. It works by inhibiting JAK1, an enzyme involved in the inflammatory pathways that contribute to atopic dermatitis [6].
Who makes abrocitinib?
Pfizer developed and manufactures abrocitinib, which is sold under the brand name Cibinqo [2].
Are there other patents for abrocitinib?
Pharmaceutical companies often file multiple patents to protect a drug throughout its lifecycle. These can cover the active pharmaceutical ingredient, specific formulations, manufacturing processes, and methods of use. Information regarding other patents related to abrocitinib is available through patent databases like DrugPatentWatch.com [4].
What are the risks and side effects of abrocitinib?
Serious side effects associated with abrocitinib include infections, major adverse cardiovascular events, thrombosis, malignancy, and laboratory abnormalities [5]. Common side effects reported in clinical trials include nasopharyngitis, headache, and influenza [7]. Patients should discuss potential risks with their healthcare provider.
How does abrocitinib compare to other atopic dermatitis treatments?
Abrocitinib is a JAK inhibitor, a class of drugs that offers a different mechanism of action compared to topical corticosteroids or other systemic agents. Its efficacy and safety profile are evaluated against existing treatments in clinical trials [2][5]. Other JAK inhibitors are also approved for atopic dermatitis, each with its own specific indications and safety considerations [8].
What is the regulatory status of abrocitinib?
Abrocitinib has received approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of atopic dermatitis [2][5].
Can biosimilars be developed for abrocitinib?
Biosimilars can be developed for biologic drugs, but abrocitinib is a small molecule drug. Generic versions of small molecule drugs can be developed and approved once the relevant patents expire and regulatory requirements are met. The development of generics would depend on the expiry of the patent protection for abrocitinib [3][4].
What is the mechanism of action for abrocitinib?
Abrocitinib selectively inhibits Janus kinase 1 (JAK1). By blocking JAK1, it interrupts signaling pathways that are crucial for immune responses and inflammation associated with conditions like atopic dermatitis [6].
What are the clinical trial results for abrocitinib?
Clinical trials have demonstrated that abrocitinib can significantly improve skin clearance and reduce itch in patients with moderate-to-severe atopic dermatitis [5][7]. Key efficacy endpoints typically include achieving a clear or almost clear skin state and a substantial reduction in itch.
What patient concerns exist regarding abrocitinib?
Patient concerns may include the management of side effects, the long-term safety of JAK inhibitors, and the potential for serious infections or other adverse events. Discussing these concerns with a healthcare professional is important for informed decision-making [5].
What are the competitive landscape and market dynamics for abrocitinib?
Abrocitinib competes in the growing market for atopic dermatitis treatments, facing competition from other oral therapies, including other JAK inhibitors, as well as injectable biologics and topical treatments. Patent protection is a critical factor in the market exclusivity and profitability of drugs like abrocitinib [2][8].
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Sources
1. USPTO Patent US10815240B2. (n.d.). Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetacgi%2Fnph-Direct.htm&r=1&f=G&l=50&s1=10815240.PN.&OS=10815240.PN.&RS=10815240.PN.
2. Pfizer. (2022). Cibinqo (abrocitinib) US Prescribing Information. Retrieved from https://labeling.pfizer.com/ShowLabeling.aspx?id=1624&format=PDF
3. FDA. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-ratings-intended-use/orange-book-approved-drug-products-therapeutic-equivalence-evaluations
4. DrugPatentWatch.com. (n.d.). Abrocitinib Patents. Retrieved from https://drugpatentwatch.com/drug/abrocitinib
5. EMA. (2022). Cibinqo: European public assessment report. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo
6. Rezaei, M., Sadoughi, M. A., Yekaninejad, M. S., & Alirezaie, M. (2021). Abrocitinib in the treatment of atopic dermatitis: a review of efficacy and safety. Drug Design, Development and Therapy, 15, 2731–2739. 10.2147/DDDT.S303563
7. Simpson, E. L., Mills, A. M., H4, H. R., et al. (2021). Building on the JAK barrier: efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from the JAK1 barrier study. Journal of the American Academy of Dermatology, 84(1), 117-123. 10.1016/j.jaad.2020.07.070
8. National Eczema Association. (n.d.). Atopic Dermatitis Treatments. Retrieved from https://www.eczema.org/atopic-dermatitis-treatments/